EYP-1901 for Diabetic Macular Edema

(VERONA Trial)

Recruiting at 5 trial locations

Overseen By Ramiro Ribeiro, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: EyePoint Pharmaceuticals, Inc.

Must be taking: Anti-VEGF

Disqualifiers: Ocular disease, Inflammation, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

27 Participants Needed

Trial Summary

What is the purpose of this trial?

A prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept

Research Team

Ramiro Ribeiro, MD

Principal Investigator

EyePoint Pharmaceuticals

Eligibility Criteria

This trial is for people with diabetic macular edema (DME), a type of eye swelling. Participants must have a certain level of vision in the affected eye and have been treated with an anti-VEGF injection within the last 6 months but not less than 8 weeks before screening.

Inclusion Criteria

My vision in the study eye is between 20/200 and 20/32.

I have been diagnosed with diabetes affecting my eye before the screening visit.

I've had an eye injection treatment in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of either EYP-1901 or Aflibercept

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Multiple visits (in-person)

Treatment Details

Interventions

• EYP-1901

Trial Overview The study compares two doses of EYP-1901, which is administered as an intravitreal insert, against aflibercept injections. It's designed to assess how well these treatments work and their safety for patients with DME.

Participant Groups

Group I: EYP-1901 2686 µg Experimental Treatment 1 Intervention

EYP-1901 2686 µg, single dose

Group II: EYP-1901 1343 µg Experimental Treatment 1 Intervention

EYP-1901 1343 µg, single dose

Group III: Aflibercept Active Control 1 Intervention

Aflibercept 2 mg/0.05mL solution, single dose

Who Is Running the Clinical Trial?

EyePoint Pharmaceuticals, Inc.

Lead Sponsor

Trials

19

Recruited

2,700+